1.  The whole of this instrument

1 November 2022

1 November 2022

Burosumab

C13330 C13377 C13400

Sufficient for treatment for 4 weeks

5

Burosumab

C13330

X-linked hypophosphataemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13377

X-linked hypophosphataemia
Initial treatment - New patient
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13400

X-linked hypophosphataemia
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2022; AND
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have, prior to commencing non-PBS-subsidised supply, a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures